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Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)

Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2) - Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027851
Enrollment
700
Registered
2017-06-21
Start date
2015-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

Patients were treated with Ledipasvir and Sofosbuvir combination therapy

Sponsors

Nippon Medical School Chiba Hokusoh Hospital
Lead Sponsor
Nippon Medical School Hospital Nippon Medical School Musashi Kosugi Hospital The Jikei University Hospital Otakanomori Hospital Hakujikai Healthcare foundation Tokyo Metropolitan Bokutoh Hospital Tokyo Medical University Ibaraki Medical Center Shinmatsudo Central General Hospital Japanese Red Cross Narita Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis C who treat with Ledipasvir/Sofosbuvir combination therapy.

Exclusion criteria

Exclusion criteria: 1.History of allergy to Ledipasvir and Sofosbuvir. 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2) 8.Receiving contraindicated drugs for Ledipasvir and Sofosbuvir combined therapy

Design outcomes

Primary

MeasureTime frame
Sustained virological response rate

Secondary

MeasureTime frame
1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3.Change of renal function during a treatment period 4. Frequency of a side effect during a treatment period 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

Countries

Japan

Contacts

Public ContactMasanori Atsukawwa

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

atsukawa-nms@umin.ac.jp0476-99-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026